On July 11, 2016, the Institute for Clinical and Economic Review (ICER) initiated a review process assessing the comparative clinical effectiveness of new and emerging drug therapies for the treatment of rheumatoid arthritis (RA). The review will result in a report that could be utilized by payers to inform RA treatment protocols and/or impose utilization management. United Rheumatology (UR) issued a response to ICER’s call for Public Comment that ended August 1, as well as a response to its Draft Scoping Document on August 22. UR’s input, while not yet publicly posted, was considered in development of the RA Revised Scoping Document released on August 29, and UR remains in dialogue with ICER as the next phases of its review process proceed. As additional information becomes available, UR members will be kept apprised.
ICER Background Information
ICER is self-described as a non-profit organization that “evaluates evidence on the value of medical tests, treatments, and delivery system innovations and moves that evidence into action to improve the healthcare system,” for which it has received significant scrutiny from a number of organizations including pharmaceutical companies and patient groups. ICER responded to these concerns in its August 9, 2016 publication, “Addressing the Myths About ICER and Value Assessment.” Among the concerns addressed are ICER’s funding sources, consideration of the patient’s perspective, the impact of reviews on research and innovation, and the organization’s role within the health insurance industry.
In CMS’s recently proposed Medicare Part B Drug Demonstration, it specifically mentioned ICER in relationship to the program’s proposed second phase, in which value frameworks would be used to control drug spending. Dr. Stephen Pearson, ICER’s founder, participated in a July 27 interview with USA Today, where he defended ICER’s intentions, noting that while he “completely understand[s] the concern [that access to drugs could be negatively impacted], however, we don’t make formal coverage recommendations… we try to be that independent voice that has been lacking in the U.S. healthcare system.” Additional information regarding ICER’s approach to indication-specific pricing – another emerging and important topic to the practice of rheumatology – can be found within its 2015 ICER Membership Policy Summit report published in March 2016.
- ICER’s July 11,2016 announcement for its Review of RA Treatments
- ICER’s August 1, 2016 Rheumatoid Arthritis Draft Scoping Document
- iii.ICER’s August 29, 2016 Rheumatoid Arthritis Revised Scoping Document
- Key upcoming dates in ICER’s RA Review Process
- ICER’s August 9, 2016 publication “Addressing the Myths About ICER and Value Assessment”
- For additional information about the Medicare Part B Drug Demonstration, see United Rheumatology’s most recent post.
- 2015 ICER Membership Policy Summit report
Dr. Pearson’s July 27 interview with USA Today.